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Completed

NCT Number: NCT01776658

Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.

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Key information

Conditions

Ocular Pain Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Eye Manifestations Eye Pain Lacrimal Apparatus Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fundación Jiménez Díaz, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both genders
  • Age ≥ 18 years old
  • Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
  • Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:
  • OSDI scale: 13-30
  • VAS scale: 2-7
  • Ocular tests in both eyes:
  • Corneal staining with fluorescein. Oxford scale > 0
  • Tear Breakup Time Test: (BUT) < 10 seconds
  • Schirmer test with anaesthesia < 10 mm/5min

Exclusion criteria

  • Pregnant or breastfeeding females or those with a positive pregnancy test.
  • Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study.
  • Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
  • Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
  • Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
  • Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.
  • Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.
  • Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.
  • Previous history of drug hypersensitivity.
  • Use of contact lenses
  • Case history of drug or alcohol abuse or dependence.
  • Relevant abnormal laboratory results as judged by the investigator
  • Previous refractive surgery
  • Participation in a clinical trial within 2 months before the enrolment visit
  • Relevant ocular pathology judged by the investigator.

Treatment and study plan

SYL1001

Drug

Ocular topical administration of SYL1001 for 10 consecutive days

Placebo

Drug

Ocular topical administration of placebo for 10 consecutive days

Primary outcomes

  1. Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo.

    Time frame: 10 days + (4-10 days)

  2. Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp

    Time frame: 10 days + (4-10 days)

Secondary outcomes

  1. Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability

    Time frame: 10 days + (96-240 hours)

  2. Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product

    Time frame: 10 days + (96-240 hours)

Sponsors and collaborators

Lead sponsor

Sylentis, S.A.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
First posted
Jan 28, 2013
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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